Atorvastatin in Relapsing-Remitting Multiple Sclerosis - Tabular View

Tracking Information

First Received Date ^ICMJE

February 5, 2008

Last Updated Date

February 14, 2008

Start Date ^ICMJE

October 2003

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

number of MRI contrast enhancing lesions [ Time Frame: treatment months 6 to 9 compared to baseline ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00616187 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

other MRI-based parameters (CEL volume, T2-lesion load, T1-hypointense lesion volume, whole brain magnetization transfer ratio, and apparent diffusion coefficient of normal appearing white matter) [ Time Frame: treatment months 6 to 9 compared to baseline ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Atorvastatin in Relapsing-Remitting Multiple Sclerosis

Official Title ^ICMJE

Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis

Brief Summary

A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Parallel Assignment

Condition ^ICMJE

Relapsing Remitting Multiple Sclerosis

Intervention ^ICMJE

Drug: interferon beta treatment to add-on atorvastatin treatment
Drug: untreated to atorvastatin treatment

Study Arms / Comparison Groups

Publications *

Paul F, Waiczies S, Wuerfel J, Bellmann-Strobl J, Dörr J, Waiczies H, Haertle M, Wernecke KD, Volk HD, Aktas O, Zipp F. Oral high-dose atorvastatin treatment in relapsing-remitting multiple sclerosis. PLoS ONE. 2008 Apr 9;3(4):e1928.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 - 55 years old
MS diagnosis according McDonald criteria
Relapsing-remitting MS
EDSS 0 - 6
Disease activity as occurrence of CEL in brain MRI
IFN-beta therapy for at least 6 months

Exclusion Criteria:

Primary chronic progressive MS
Symptoms and signs of clinical disease conditions similar to MS
Conditions that can disturb MRI measurements
Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus pepticum
Clinically relevant lung, heart, CNS, infectious disease
Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific clinical chemistry values)
Allergies towards Gd-DTPA
Allergies towards constituents of the therapeutic agent
Recruitment to other clinical trials within 6 months prior to or during this study
Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A, human antibodies, all immunomodulatory or immunosuppressive agents including recombinant cytokines or other potential experimental MS therapies (6 months prior to study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start) pregnancy or lactation
Alcohol or drug abuse
Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole antimycotics).
Medical or psychological conditions that could hamper with the patients capacity to understand patient information, to give the informed consent, to adhere to the protocol of the study and to be able to complete the study

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00616187

Responsible Party

Professor Frauke Zipp, Cecilie Vogt Clinic for Neurology, Charite University, Berlin, Germany

Study ID Numbers ^ICMJE

1931/Si.270 am 8.5.03, ATV-D-03-007G

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

German Research Foundation
German Federal Ministry of Education and Research
Pfizer

Investigators ^ICMJE

Principal Investigator:

Frauke Zipp, MD

Cecilie Vogt Clinic for Neurology, Charite, Berlin

Information Provided By

Charite University, Berlin, Germany

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP